A Phase 2 interventional study of SHR6390 and Anastrozole in Breast Cancer, HER2-positive Breast Cancer and ER-positive Breast Cancer, sponsored by Ruijin Hospital. Status unknown. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 37 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SHR6390 · Drug: Anastrozole · Drug: Pyrotinib · Drug: Trastuzumab
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles
Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)
Pyrotinib 400mg once daily for 16 weeks
Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.
Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy
Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy
Time frame: 2 weeks
Ki67 changes from baseline to at surgery
Ki67 changes from baseline to at surgery
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Pathological complete response (ypT0/is ypN0) rate
Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Objective response rate (ORR)
ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1
Time frame: average 19 weeks after the start of the neoadjuvant therapy
Invasive disease-free survival (IDFS)
IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)
Time frame: 5 years
Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped
Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Time frame: during treatment (16 weeks)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital